The following data is part of a premarket notification filed by Abigo Medical Ab with the FDA for Sorbact.
Device ID | K100591 |
510k Number | K100591 |
Device Name: | SORBACT |
Classification | Dressing, Wound, Drug |
Applicant | ABIGO MEDICAL AB 435 RICE CREEK TERRACE NE, Fridley, MN 55432 |
Contact | Constance Bundy |
Correspondent | Constance Bundy ABIGO MEDICAL AB 435 RICE CREEK TERRACE NE, Fridley, MN 55432 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-02 |
Decision Date | 2011-01-24 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SORBACT 78783802 3593114 Live/Registered |
Abigo Medical AB 2006-01-03 |
SORBACT 76376403 not registered Dead/Abandoned |
Abigo Medical AB 2002-03-01 |
SORBACT 73532358 1405443 Dead/Cancelled |
LANDSTINGENS INKOPSCENTRAL LIC 1985-04-15 |